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Relapsed/Refractory Multiple MyelomaMoMMentNCT05160584

A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma

An observational study of Relapsed/Refractory Multiple Myeloma, run by Janssen Pharmaceutica N.V., Belgium at 90 sites in 12 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety and patient-reported outcomes (PROs) associated with standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed/Refractory Multiple Myeloma
How many people
256 participants
Where
90 sitesin 12 countries
Study dates
18 Nov 2021to 30 Oct 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population consists of participants with previously treated multiple myeloma, having received standard of care (SOC) antimyeloma treatments during local clinical practices.

Who may be able to join

  • For Period 1 and 2: Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria. For Period 3: Start of talquetamab for the treatment of a documented diagnosis of relapsed and/or refractory multiple myeloma (RRMM) according to IMWG diagnostic criteria and the approved indication. The decision to start talquetamab must be made independently of the decision to participate in the study, with the start of treatment occurring up to 28 days following the start of screening or having occurred up to 21 days before the informed consent form (ICF) date
  • For Period 1 and 2: Have an Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1. For Period 3: Have ECOG performance status of 0,1 or 2
  • For Period 1,2 and 3: Must not be pregnant or must not plan to become pregnant within the study period
  • For Period 1,2 and 3: Participants must sign an ICF indicating that he or she understands the purpose and observational nature of the study and is willing to participate. Consent is to be obtained prior to the initiation of any study-related data collection
  • For Period 1 and 2: Received at least 3 prior lines of therapy (induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen). Undergone at least 1 complete cycle of treatment for each line of therapy, unless progressive disease (PD) was the best response to the line of therapy
  • For Period 1 and 2: Must have documented evidence of progressive disease based on participating physician's determination of response by the IMWG response criteria on or after the last regimen. Participants with documented evidence of progressive disease within the previous 6 months and who are refractory or non-responsive to their most recent line of treatment afterwards are also eligible
Show all 10Show fewer
  • For Period 1 and 2: Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level 1.0 g/dL or urine M-protein level 200 mg/24 hours; or Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
  • Period 1: Received as part of previous therapy a PI, an IMiD, and an anti-CD38 antibody (prior exposure can be from different monotherapy or combination regimens)
  • Period 2: Received as part of previous therapy a PI, an IMiD, an anti-CD38 antibody, and BCMA-targeted therapy (prior exposure can be from different monotherapy or combination regimens)
  • For period 3: At least one of the following prior to the start of talquetamab: a. Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) or urine M-protein level >= 200 milligram (mg) /24 hours; or b. serum immunoglobulin free light chain >= 10 milligrams per deciliter (mg/dL) and abnormal ratio of involved and uninvolved free light chains or c. presence of bone lesions or plasmacytomas (>=1 lesion has 2 diameters >= 1 centimeter [cm])

Who cannot join

None listed.

Trial locations and contacts

90 sites in 12 countries.

90 sites in 12 countries

Italy21 sites
  • Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II

    Bari, 70124

  • U.O. Ematologia Istituto Tumori Giovanni Paolo II

    Bari, 70124

  • Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi

    Bologna, 40138

  • Policlinico di Catania

    Catania, 95128

  • Ospedale Civile di Civitanova Marche

    Civitanova Marche, 62012

  • IRCCS Azienda Ospedaliera San Martino - IST

    Genova, 16132

  • Ospedale Policlinico San Martino IRCCS

    Genova, 16132

  • Ospedale Vito Fazzi

    Lecce, 73100

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014

  • Universita degli Studi di Padova Azienda Ospedaliera di Pa

    Padova, 35128

  • Ospedale Villa Sofia-Cervello

    Palermo, 90146

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Presidio Ospedaliero Pescara

    Pescara, 65124

  • Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria

    Reggio Calabria, 89124

  • Università di Roma La Sapienza

    Roma, 00161

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168

  • Campus Bio Medico di Roma

    Roma, 128

  • Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo, 71013

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

  • Ospedale Cardinale G. Panico

    Tricase, 73039

  • Azienda Ulss 8 Berica- Ospedale Di Vicenza

    Vicenza, 36100

Other trials in Italy

Spain16 sites
  • Inst. Cat. Doncologia-H Duran I Reynals

    Barcelona, 08908

  • Hosp. de Cabuenes

    Gijón, 33394

  • Hosp. Univ. Virgen de Las Nieves

    Granada, 18014

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407

  • Hosp. de Leon

    León, 24008

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. Son Espases

    Palma, 7120

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010

  • Hosp. Univ. Dr. Peset

    Valencia, 46017

  • Hosp. Clinico Univ. de Valladolid

    Valladolid, 47003

  • Hosp. Univ. Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Germany12 sites
  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berin, 12203

  • Universitaetsklinikum Koeln

    Cologne, 50397

  • Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden

    Dresden, 01307

  • Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik

    Hamburg, 20251

  • St. Barbara-Klinik Hamm GmbH

    Hamm, 59073

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Staedtisches Klinikum Karlsruhe gGmbH

    Karlsruhe

  • MVZ Mitte-Onkologische Schwerpunktpraxis

    Leipzig, 04103

  • Universitaetsklinikum Leipzig

    Leipzig, 4103

  • Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany

    Tübingen, 72076

  • Universitatsklinikum Wurzburg

    Würzburg, 97080

  • Heinrich-Braun-Klinikum gGmbH

    Zwickau, 08060

Other trials in Germany

Greece9 sites
  • University Hospital of Alexandroupolis

    Alexandroupoli, 68100

  • Henry Dunant Hospital Center

    Athens, 115 26

  • Laiko General Hospital Of Athens 1

    Athens, 115 27

  • Laiko General Hospital of Athens 2

    Athens, 115 27

  • Alexandra Hospital

    Athens, 115 28

  • Metaxa Cancer Center Hospital Of Piraeus

    Piraeus, 18537

  • General University Hospital of Patras

    Rio, 265 04

  • Anticancer Hospital of Thessaloniki Theageneio

    Thessaloniki, 546 39

  • Ahepa University General Hospital of Thessaloniki

    Thessaloniki, 54636

Other trials in Greece

United Kingdom7 sites
  • Southmead Hospital

    Bristol, BS10 5NB

  • University College Hospital

    London, NW1 2PG

  • Kings College Hospital

    London, SE5 9RS

  • St Georges Hospital

    London, SW17 OQT

  • Maidstone Hospital

    Maidstone, ME16 9QQ

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

  • The Royal Marsden NHS Trust Sutton

    Surrey, SM2 5PT

Other trials in United Kingdom

Belgium6 sites
  • UZ Antwerpen

    Edegem, 2650

  • Ziekenhuis Oost-Limburg

    Genk, 3600

  • UZ Leuven

    Leuven, 3000

  • Chu Helora Hospital De Mons Site Kennedy

    Mons, 7000

  • Vitaz

    Sint-Niklaas, 9100

  • Ucl de Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

France5 sites
  • CHRU de Lille Hopital Claude Huriez

    Lille, 59037

  • CHU de Montpellier Hopital Saint Eloi

    Montpellier, 34295

  • CHU de Nantes hotel Dieu

    Nantes, 44093

  • Centre hospitalier Lyon-Sud

    Pierre-Bénite, 69495

  • Pôle IUC Oncopole CHU

    Toulouse, 31059

Other trials in France

Switzerland4 sites
  • Kantonsspital Graubunden

    Chur, 7000

  • Kantonsspital Winterthur, Medizinische Onkologie

    Winterthur, 8400

  • Hirslanden Klinik Hirslanden

    Zurich, 8032

  • Universitatsspital Zurich

    Zurich, 8091

Other trials in Switzerland

Portugal3 sites
  • Ulstmad - Hosp. Chaves

    Chaves, 5400 482

  • Uls Coimbra - Hosp. Univ. Coimbra

    Coimbra, 3004 561

  • Uls Sao Joao - Hosp. Sao Joao

    Porto, 4200 319

Other trials in Portugal

Romania3 sites
  • Fundeni Clinical Institute

    Bucharest, 022328

  • Spitalul Clinic Coltea, Clinica Hematologie

    Bucharest

  • Institutul Oncologic Prof Dr. Ion Chiricuta Cluj Napoca 1

    Cluj-Napoca, 400015

Other trials in Romania

Austria2 sites
  • LKH Leoben

    Leoben, 8700

  • Krankenhaus der barmherzigen Schwestern

    Vienna, 1060

Other trials in Austria

Netherlands2 sites
  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • UMCG

    Groningen, 9713 GZ

Other trials in Netherlands

About this study

Official title: A Prospective, Multinational Study of Real-Life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma

The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety and patient-reported outcomes (PROs) associated with standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma.

Being tested
No intervention
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    There is no interventional treatment component for participants with RRMM in this study.

Study groups in NCT05160584
Study groupRoleWhat they receive
Participants with Relapsed/Refractory Multiple MyelomaParticipants with relapsed/refractory multiple myeloma (RRMM) receiving antimyeloma treatment as standard of care (SOC) under routine clinical practice will be observed. The primary data source will be medical records of each participant.
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    Overall Response Rate is defined as the percentage of participants who achieve a partial response (PR) or better response according to the International Myeloma Working Group (IMWG) response criteria, as assessed by Response Review Committee (RRC).

    Measured: Up to 52 months

Secondary outcomes (20)
  1. Very Good Partial Response (VGPR) Rate

    VGPR rate is defined as the percentage of participants who achieve a VGPR or better response according to IMWG response criteria.

    Measured: Up to 52 months

  2. Complete Response (CR) Rate

    CR rate is defined as the percentage of participants who achieve a CR or better response according to IMWG response criteria.

    Measured: Up to 52 months

  3. Stringent Complete Response (sCR) Rate

    sCR rate is defined as the percentage of participants who achieve a sCR according to IMWG response criteria.

    Measured: Up to 52 months

  4. Minimal Residual Disease (MRD) Negative Rate

    MRD negative rate is defined as the percentage of participants with negative MRD status according to IMWG response criteria.

    Measured: Up to 52 months

  5. Clinical Benefit Rate (CBR)

    CBR is defined as the percentage of participants with clinical benefit. CBR=ORR (sCR + CR + VGPR + PR) + minimal response (MR).

    Measured: Up to 52 months

  6. Duration of Response (DOR)

    DOR is defined as time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease as defined in the IMWG criteria.

    Measured: Up to 52 months

  7. Time to Response (TTR)

    TTR is defined as the time between the date of Day 1 of Cycle 1 and the first clinical response evaluation that the participant has met all criteria for PR or better response.

    Measured: Up to 52 months

  8. Time to Best Response

    Time to best response is defined as the time between the date of Day 1 of Cycle 1 and best objective response.

    Measured: Up to 52 months

  9. Time to Next Treatment (TTNT)

    TTNT is defined as the time from diagnosis to the start of the next-line treatment.

    Measured: Up to 52 months

  10. Progression-free Survival (PFS)

    PFS is defined as the time from the date of Day 1 of Cycle 1 to the date of first documented disease progression (as defined in the IMWG response criteria) or death due to any cause, whichever occurs first.

    Measured: Up to 52 months

  11. Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death, Whichever Occurs First (PFS2)

    PFS2 is defined as the time from the date of Day 1 of Cycle 1 to progression on the next line of subsequent antimyeloma therapy or death, whichever occurs first.

    Measured: Up to 52 months

  12. Overall Survival (OS)

    OS is the duration from the date of Day 1 of Cycle 1 to the date of the participant's death or study completion, whichever occurs first.

    Measured: Up to 52 months

  13. Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score

    The EORTC-QLQ-C30 Version 3 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.

    Measured: Baseline up to 52 months

  14. Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)

    The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

    Measured: Baseline up to 52 months

  15. Period 1 and 2: Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EORTC QLQ-IL39

    EORTC QLQ-IL39 (four single items from the EORTC QLQMY20) will be performed to assess emotional health status (feel restless or agitated, thinking about your illness, worried about dying, worried about health in the future) on scale of 1 (not at all) to 4 (very much).

    Measured: Baseline up to 52 months

  16. Number of Participants with Adverse Events (AEs)

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

    Measured: Up to 52 months

  17. Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)

    Severity of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death related to adverse event.

    Measured: Up to 52 months

  18. Period 3: Number of Participants Reporting Oral Toxicities Using Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    PRO-CTCAE consist of 1-8 questions of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference of the AEs. The following items were selected for inclusion for patients with multiple myeloma: nausea, vomiting, diarrhea, shortness of breath, rash, dizziness, headache, taste changes, and fatigue/tiredness/lack of energy.

    Measured: Up to 52 months

  19. Period 3: Number of Participants Reporting Oral Toxicity Symptoms Using the Epstein Taste Survey (ETS)

    The Epstein Taste Survey consists of 17 items from the full 71 item PRO instrument, specific to taste changes. Developed for use in patients with head and neck cancer.

    Measured: Up to 52 months

  20. Period 3: Percentage of Participants with Overall Response to Subsequent Therapies

    Overall Response Rate is defined as the percentage of participants who achieve a partial response (PR) or better response according to the International Myeloma Working Group (IMWG) response criteria, as assessed by Response Review Committee (RRC). Overall response for subsequent therapies, including BCMA-targeted therapies after treatment with talquetamab will be reported.

    Measured: Up to 52 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2021
  2. Study start18 Nov 2021
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05160584
Sponsor's protocol ID
CR109118
Other IDs
64407564MMY4001
Acronym
MoMMent
Status last verified
Nov 2026
First submitted
15 Dec 2021
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Publications

  • Einsele H, Moreau P, Bahlis N, Bhutani M, Vincent L, Karlin L, Perrot A, Goldschmidt H, van de Donk NWCJ, Ocio EM, Martinez Lopez J, Rodriguez-Otero P, Dytfeld D, Jakubowiak A, Schinke C, Besemer B, Anguille S, Manier S, Rasche L, Teipel R, Scheid C, Pawlyn C, Cavo M, Diels J, Ghilotti F, Lau BW, Renaud T, Orel O, Ong F, Ramos DF, Ammann E, Parekh T, Albrecht C, Weisel K, Mateos MV. Comparative Efficacy of Talquetamab vs. Real-World Physician's Choice of Treatment in Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma: Updated Analyses of MonumenTAL-1 vs. LocoMMotion/MoMMent. Adv Ther. 2026 Jan;43(1):333-355. doi: 10.1007/s12325-025-03409-y. Epub 2025 Nov 28.

    PubMed 41313549
  • Einsele H, Moreau P, Bahlis N, Bhutani M, Vincent L, Karlin L, Perrot A, Goldschmidt H, van de Donk NWCJ, Ocio EM, Martinez-Lopez J, Rodriguez-Otero P, Dytfeld D, Diels J, Strulev V, Haddad I, Renaud T, Ammann E, Cabrieto J, Perualila N, Gan R, Zhang Y, Parekh T, Albrecht C, Weisel K, Mateos MV. Comparative Efficacy of Talquetamab vs. Current Treatments in the LocoMMotion and MoMMent Studies in Patients with Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma. Adv Ther. 2024 Apr;41(4):1576-1593. doi: 10.1007/s12325-024-02797-x. Epub 2024 Feb 24.

    PubMed 38402374
  • Moreau P, Mateos MV, Gonzalez Garcia ME, Einsele H, De Stefano V, Karlin L, Lindsey-Hill J, Besemer B, Vincent L, Kirkpatrick S, Delforge M, Perrot A, van de Donk NWCJ, Pawlyn C, Manier S, Leleu X, Martinez-Lopez J, Ghilotti F, Diels J, Morano R, Albrecht C, Strulev V, Haddad I, Pei L, Kobos R, Smit J, Slavcev M, Marshall A, Weisel K. Comparative Effectiveness of Teclistamab Versus Real-World Physician's Choice of Therapy in LocoMMotion and MoMMent in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma. Adv Ther. 2024 Feb;41(2):696-715. doi: 10.1007/s12325-023-02738-0. Epub 2023 Dec 19.

    PubMed 38110653

Questions about this trial

What is this clinical trial studying?

An observational study of Relapsed/Refractory Multiple Myeloma, run by Janssen Pharmaceutica N.V., Belgium at 90 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in Italy, Spain, Germany, Greece, United Kingdom and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Up to 52 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05160584, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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